Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2).

Chong Lei; Binxiao Su; Hailong Dong; Andrea Bellavia; Raffaele Di Fenza; Bijan Safaee Fakhr; Stefano Gianni; Luigi Giuseppe Grassi; Robert Kacmarek; Caio Cesar Araujo Morais; Riccardo Pinciroli; Emanuele Vassena; Lorenzo Berra

Patients enrolled in other clinical interventional trials investigating potential targeted therapies against 2019-nCoV do not exclude participation to this trial. Patients in the treatment arm receive iNO at 80 ppm for the first 48 hours after enrollment, then reduce to 40 ppm until severe hypoxemia resolves. Weaning from NO will start when patients improve the level of oxygenation to PaO2/FiO2> 300 mmHg for more than 24 hours consecutively. Since abrupt discontinuation of iNO can sometimes result in rebound pulmonary hypertension, with possible oxygenation impairment and acute right heart failure, gradual discontinuation will be performed. Physicians will follow their own institution weaning protocols. In absence of institutional protocols, iNO will be reduced every 4 hours in stepwise fashion starting from 40 ppm to 20, 10, 5, 3, 2 and 1 ppm. If case of hypoxemia (SpO2< 93%) or acute hypotension (systolic blood pressure < 90 mmHg) during weaning, iNO should be increased to the prior higher concentration.